How Will Pharma Sponsors Comply With PDUFA VI Requirements Related To Collecting/Submitting "Voice Of The Patient" Data As Part Of Their NDA?

Source: Life Science Leader
Sandy MacRae Sangamo

A | SUCCESSFUL COMPLIANCE WITH THESE GUIDELINES requires close collaboration and open communication with advocacy organizations and other patient-focused groups. It’s also important to work closely with the FDA to encourage and support their efforts to ensure rare disease patient communities will have equal access and representation under these new guidelines.

At Sangamo we’ve already begun operationalizing how we integrate the patient voice throughout our therapeutic development process. Throughout the year, we invite patients and their families to visit and share their experiences with our employees so that each one of us understands and incorporates patients’ needs into the development of our genomic medicines.

SANDY MACRAE, M.B., CH.B., PH.D., is CEO of Sangamo Therapeutics. He has over 20 years of leadership experience in the pharmaceutical industry.